Biotech Values

[AlpineBV_Miller]

It has absolutely no bearing on the prospects or viability of an ongoing phase III program. In other words, a company with an ongoing phase III trial that starts a rolling NDA submission isn't sending a covert message to investors that the trial is a success.

I'd go so far as to say any company who makes a big deal about the BLA/NDA being "rolling" -- i.e. constantly harping on what an advantage it gives them, how the company has such a close working relationship with the FDA the FDA is "allowing" a rolling BLA/NDA, and/or how it will speed review -- should be looked at with suspicion.

Either they are trying to hype things or they are so naive they don't realize any Fast Track app explicitly allows rolling submission.

FYI, the FDA doesn't begin review or the review clock until the final segment of the application is in. Many new biotech investors don't understand this point and some shady companies imply otherwise.